FDA approves Empagliflozin for reducing kidney disease progression in CKD patients

The U.S. Food and Drug Administration (FDA) has granted approval for empagliflozin 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.

This approval for isolated CKD is primarily based on the results of the EMPA-KIDNEY trial.

In the EMPA-KIDNEY trial, 6,609 adults with CKD and specific eGFR (glomerular filtration rate) and urinary albumin-to-creatinine ratio criteria were randomly assigned to receive either empagliflozin or a placebo. After a median follow-up period of 2.0 years, the trial demonstrated a significant 28% relative reduction in the primary endpoint—a composite of kidney disease progression or death from cardiovascular causes—in the empagliflozin group compared to the placebo group.

The strong evidence supporting the effectiveness and safety of both dapagliflozin and empagliflozin in adults with isolated CKD led the Kidney Disease: Improving Global Outcomes (KDIGO) organization to include a practice recommendation for SGLT2 inhibitor treatment in its draft 2023 updated guideline for CKD management. The draft guideline suggests treating adults with specific eGFR and albumin-to-creatinine ratio criteria with an SGLT2 inhibitor.

Empagliflozin had already received FDA approval for three other indications: reducing the risk of cardiovascular death and heart failure hospitalization in adults with heart failure (regardless of left ventricular ejection fraction); reducing the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease; and lowering blood sugar in adults and children aged 10 or older with type 2 diabetes when used alongside diet and exercise.